NCT03435744

Brief Summary

In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

February 9, 2018

Last Update Submit

August 25, 2021

Conditions

Treatment Resistant DepressionMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)

    The MADRS will be used as primary outcome measure in estimating depression severity

    Week-2, Week-4, Week-8 and Week-12

Study Arms (2)

Simvastatin with TAU

EXPERIMENTAL

Participants will receive Simvastatin 20 mg added to TAU for 3 months

Drug: Simvastatin 20 mg

Placebo Oral Tablet with TAU

PLACEBO COMPARATOR

Participants will receive placebo added to TAU for 3 months

Other: Placebo Oral Tablet

Interventions

Simvastatin 20 mgDRUG

Simvastatin 20 mg added to TAU for 3 months.

Also known as: Statins
Simvastatin with TAU
Placebo Oral TabletOTHER

Matched placebo added to TAU for 3 months

Placebo Oral Tablet with TAU

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-5 current major depressive episode
  • Must currently be on an antidepressant and must have had a non-response to \>2 oral antidepressant treatments in the current episode (including the one they are currently taking).
  • Capacity to give informed consent
  • Willing to use adequate contraception
  • Give written informed consent

You may not qualify if:

  • Primary psychotic or bipolar disorder
  • History of intolerance to statins or presence of any contraindication to statins
  • Presence of any serious medical condition or neurological problem
  • Presence of autoimmune or inflammatory disorder
  • Alcohol or drug dependence
  • Active suicidal ideation
  • Pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Civil Hospital

Hyderābād, Pakistan

Location

Civil Hospital

Karachi, 75500, Pakistan

Location

Abbasi Shaheed Hospital

Karachi, Pakistan

Location

Institute of Professional Psychology

Rawalpindi, Pakistan

Location

Related Publications (2)

  • Husain MI, Chaudhry IB, Khoso AB, Kiran T, Khan N, Ahmad F, Hodsoll J, Husain MO, Naqvi HA, Nizami AT, Chaudhry N, Khan HA, Minhas F, Meyer JH, Ansari MA, Mulsant BH, Husain N, Young AH. Effect of Adjunctive Simvastatin on Depressive Symptoms Among Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230147. doi: 10.1001/jamanetworkopen.2023.0147.

    PMID: 36808239DERIVED

  • Husain MI, Chaudhry IB, Khoso AB, Husain MO, Rahman RR, Hamirani MM, Hodsoll J, Carvalho AF, Husain N, Young AH. Adjunctive simvastatin for treatment-resistant depression: study protocol of a 12-week randomised controlled trial. BJPsych Open. 2019 Jan;5(1):e13. doi: 10.1192/bjo.2018.84.

    PMID: 30762508DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, Major

Interventions

SimvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind plcaebo controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1-Simvastatin plus TAU, 2- Placebo plus TAU
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 19, 2018

Study Start

January 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(4)